Download Informed Consent

Sample consent form version: August 15, 2013
To be attached to protocol version: August 15, 2013
APPENDIX I
Informed Consent Template for Cancer Treatment Trials
(English Language)
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NATURAL HISTORY OF POSTOPERATIVE COGNITIVE FUNCTION, QUALITY OF LIFE,
AND SEIZURE CONTROL IN PATIENTS WITH SUPRATENTORIAL LOW-RISK GRADE II
GLIOMA
This is a clinical trial, a type of research study. Your study doctor will explain the clinical trial to you.
Clinical trials include only people who choose to take part. Please take your time to make your decision
about taking part. You may discuss your decision with your friends and family. You can also discuss it
with your health care team. If you have any questions, you can ask your study doctor for more
explanation.
You are being asked to take part in this study because you have a slow growing brain tumor called a low
grade glioma.
Why is this study being done?
The purpose of this study is to understand the effects of your brain tumor and surgery on your cognitive
function (thinking abilities, memory), quality of life, and seizures.
How many people will take part in the study?
About 170 people will take part in this study.
What will happen if I take part in this research study?
Before you begin the study …
Your study doctor will need to send the block of tumor tissue obtained at the time of your brain tumor surgery to a
central pathology site. There, a pathologist will confirm that the tumor is a low-grade glioma. If the tumor is not a
low-grade glioma, you will not be able to continue in the study.
If the tumor is a low-grade glioma, you will need to have the following exams, tests or procedures to find out if you
can continue in the study. These exams, tests or procedures are part of regular cancer care and may be done
even if you do not join the study. If you have had some of them recently, they may not need to be repeated. This
will be up to your study doctor.
 History and physical examination, including neurologic examination
 MRI of your brain
During the study …
If the exams, tests and procedures show that you can be in the study, and you choose to take part, then you will
need the following tests and procedures. They are part of regular cancer care.
 History and physical examination, including neurologic examination, every 6 months
 MRI of your brain every 6 months
The study will also consist of the following:
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
A 20-25 minute testing session that will measure some aspects of your thinking functions, such
as your memory. The testing sessions will be conducted when you enter the study and then at
12, 24, 36, 42, 48, 54, and 60 months after you enter the study. You will also have an additional
testing session before you undergo any further treatment for your tumor (re-operation, radiation,
or chemotherapy).
o You will do these tasks on a computer. You do not need to be familiar with computers to
complete the tasks, and you won’t have to type—you only need to press one of two
buttons. The tasks are not like tests given in school; they are like games.
o


The computer used for the cognitive tasks will be located in a quiet area relatively free of
distractions and with reasonable lighting, comfortable seating, and a table of sufficient
size for the computer.
You will be asked to complete 3 questionnaires at the following times: on your first visit; at 12,
24, 36, 48, and 60 months afterwards; and before you undergo any further treatment for your
tumor (re-operation, radiation, or chemotherapy). It takes less than 15 minutes to fill out the
questionnaires. The questionnaires will assess how you are feeling physically and emotionally
during your cancer treatment and also how you are able to carry out your day-to-day activities. If
any questions make you feel uncomfortable, you may skip those questions and not give an
answer.
You will be asked to complete a seizure diary when you enter the study and every 6 months
while you are on the study. The diary will assess how frequently you are having seizures.
How long will I be in the study?
You will be asked to take the testing sessions for about 4 and a half years. After you have completed these
sessions, the study doctor will ask you to visit the office for follow-up exams for at least 5 years.
Can I stop being in the study?
Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping or
decide to stop.
It is important to tell the study doctor if you are thinking about stopping, so that you and your study doctor can
discuss what follow-up care and testing could be most helpful for you.
The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best
interest; if you do not follow the study rules; or if the study is stopped.
What side effects or risks can I expect from being in the study?
Your involvement in this study does not involve any physical risk to you. However, you will be asked to spend
time on tasks that you would not otherwise spend time on. There is also a very small risk that your personal
information may be released. Please review the section below, “Will my medical information be kept private?”.
For more information about risks and side effects, ask your study doctor.
Are there benefits to taking part in the study?
You may or may not benefit from participating in this study. However, the study doctors hope that the information
from this study will help researchers learn more about patients with low-grade gliomas. This information could
help future cancer patients.
What other choices do I have if I do not take part in this study?
Your other choices may include:
 Being followed for your tumor without being in a study
 Taking part in another study
Talk to your study doctor about your choices before you decide if you will take part in this study.
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Will my medical information be kept private? (12/3/12)
Data are housed at RTOG Headquarters in a password-protected database. We will do our best to make sure
that the personal information in your medical record will be kept private. However, we cannot guarantee total
privacy. Your personal information may be given out if required by law. If information from this study is published
or presented at scientific meetings, your name and other personal information will not be used.
Organizations that may look at and/or copy your medical records for research, quality assurance, and data
analysis include:
 The Radiation Therapy Oncology Group
 The National Cancer Institute (NCI) and other government agencies, like the Food and Drug
Administration (FDA), involved in keeping research safe for people
 The Cancer Trials Support Unit (CTSU), a service sponsored by the National Cancer Institute (NCI) to
provide greater access to cancer trials
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This
Web site will not include information that can identify you. At most, the Web site will include a summary of the
results. You can search this Web site at any time.
Your scores from the neurocognitive test sessions will not be shared with you or your healthcare providers and
are for research purposes only. If requested, you may receive a summary of this research study’s findings at the
conclusion of the study. The summary will discuss general findings from the study and will not contain your name
or those of other participants or a list of scores for each participant.
What are the costs of taking part in this study? (8/15/13)
You and/or your health plan/ insurance company will not need to pay for the cost of administering the memory
testing sessions. You and/or your health plan/insurance company will need to pay for some of the costs of the
clinic visits and MRIs associated with the study in conjunction with regular care for your tumor.
You will not be paid for taking part in this study.
What happens if I am injured because I took part in this study?
It is important that you tell your study doctor, __________________ [investigator’s name(s)], if you feel that you
have been injured because of taking part in this study. You can tell the study doctor in person or call him/her at
__________________ [telephone number].
You will get medical treatment if you are injured as a result of taking part in this study. You and/or your health
plan will be charged for this treatment. The study will not pay for medical treatment.
What are my rights if I take part in this study?
Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you
decide to take part in this study, you may leave the study at any time. No matter what decision you make, there
will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your
medical care. You can still get your medical care from our institution.
We will tell you about new information or changes in the study that may affect your health or your willingness to
continue in the study.
A Data Safety Monitoring Board will be regularly meeting to monitor safety and other data related to phase I, I/II,
and II RTOG clinical trials. The Board members may receive confidential patient information, but they will not
receive your name or other information that would allow them to identify you by name.
In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing
this form.
Who can answer my questions about the study?
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You can talk to your study doctor about any questions or concerns you have about this study. Contact your study
doctor __________________ [name(s)] at __________________ [telephone number].
For questions about your rights while taking part in this study, call the ________________________ [name of
center] Institutional Review Board (a group of people who review the research to protect your rights) at
__________________ (telephone number). [Note to Local Investigator: Contact information for patient
representatives or other individuals in a local institution who are not on the IRB or research team but take calls
regarding clinical trial questions can be listed here.]
*You may also call the Operations Office of the NCI Central Institutional Review Board (CIRB) at 888-657-3711
(from the continental US only). [*Only applies to sites using the CIRB.]
Please note: This section of the informed consent form is about additional research that is being done
with people who are taking part in the main study. You may take part in this additional research if you
want to. You can still be a part of the main study even if you say ‘no’ to taking part in this additional
research.
You can say “yes” or “no” to each of the following studies. Below, please mark your choice for each
study.
Consent Form for Use of Tissue, Blood, and Urine for Research
About Using Tissue, Blood, and Urine for Research
You have had a biopsy (or surgery) to see if you have cancer. Your doctor removed some body tissue to do some
tests. The results of these tests have been given to you by your doctor and are being used to plan your care.
We would like to keep some of the tissue that is left over for future research. If you agree, this tissue will be kept
and may be used in research to learn more about cancer and other diseases. Please read the information sheet
called "How is Tissue Used for Research" to learn more about tissue research. This information sheet is available
at http://cdp.cancer.gov/humanSpecimens/ethical_collection/patient.htm.
We would also like to collect for future research about three tablespoons of blood and three tablespoons of urine.
We would collect the blood and urine before you begin the first memory testing session.
The research that may be done with your specimens is not designed specifically to help you. It might help people
who have cancer and other diseases in the future.
Reports about research done with your specimens will not be given to you or your doctor. These reports will not
be put in your health record. The research will not have an effect on your care.
Things to Think About
The choice to let us keep your specimens for future research is up to you. No matter what you decide to do, it will
not affect your care or your participation in the main part of the study.
If you decide now that your specimens can be kept for research, you can change your mind at any time. Just
contact us and let us know that you do not want us to use your tissue. Then any specimens that remain will no
longer be used for research and will be returned to the institution that submitted it or destroyed.
In the future, people who do research may need to know more about your health. While the [researcher/institution]
may give them reports about your health, it will not give them your name, address, phone number, or any other
information that will let the researchers know who you are.
Sometimes specimens are used for genetic research (about diseases that are passed on in families). Even if your
specimens are used for this kind of research, the results will not be put in your health records.
Your specimens will be used only for research and will not be sold. The research done with your specimens may
help to develop new treatments for cancer in the future.
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Benefits
The benefits of research using specimens include learning more about what causes cancer and other diseases,
how to prevent them, and how to treat them.
Risks (8/15/13)
The greatest risk to you is the release of information from your health records. We will do our best to make sure that your
personal information will be kept private. The chance that this information will be given to someone else is very small.
Some of your genetic and health information may be placed in central databases that may be public, along with
information from many other people. Information that could directly identify you will not be included. The samples
are given a code to protect your privacy before they are used. Any related information given to researchers will
also be coded. Researchers will receive the code instead of any information that might directly identify you.
There can be a risk in knowing genetic information. New health information about inherited traits that might affect
you or your blood relatives could be found during a research study. Even though your genes are unique, you
share some of the same genes with your blood relatives.
Although we are not able to know all of the risks from taking part in research on inherited traits, we believe that
the risks to you and your family are very low, because your samples will be coded. Research results will not be
returned to you or your doctor.
Very rarely health or genetic information could be misused by employers, insurance companies, and others. For
example, life insurance companies may charge a higher rate based on this information.
Many states have laws to protect against genetic discrimination [list appropriate state information if your state or
locality has such laws]. Additionally, a federal law called the Genetic Information Non-Discrimination Act, or GINA,
is in effect. This law prohibits health insurer or employer discrimination. The law does not include other types of
misuse by life insurance, disability, or long term care insurance. To learn more about the GINA Law, please ask
[Note to local investigator: Contact information for patient representatives or other individuals in a local institution
who are not on the IRB or research team but take calls regarding clinical trial questions can be listed here.]
Making Your Choice
Please read each sentence below and think about your choice. After reading each sentence, circle "Yes" or "No".
If you have any questions, please talk to your doctor or nurse, or call our research review board at
__________________________ [IRB's phone number].
No matter what you decide to do, it will not affect your care.
1. My specimens may be kept for use in research to learn about, prevent, or treat cancer, as follows:
 Tissue Yes  No
 Blood Yes  No
 Urine
Yes  No
2. My specimens may be kept for use in research to learn about, prevent or treat other health problems (for
example: diabetes, Alzheimer's disease, or heart disease), as follows:
 Tissue Yes  No
 Blood Yes  No
 Urine
Yes  No
3. Someone may contact me in the future to ask me to take part in more research.
Yes  No
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Where can I get more information? (12/3/12)
You may call the National Cancer Institute's Cancer Information Service at:
1-800-4-CANCER (1-800-422-6237)
You may also visit the NCI Web site at http://cancer.gov/

For NCI’s clinical trials information, go to: http://cancer.gov/clinicaltrials/

For NCI’s general information about cancer, go to http://www.cancer.gov/cancertopics/
You will get a copy of this form.
If you want more information about this study, ask your study doctor.
Signature
I have been given a copy of all _____ [insert total of number of pages] pages of this form. I have read it or it
has been read to me. I understand the information and have had my questions answered. I agree to take
part in this study.
Participant ________________________________
Date ____________________________________
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